FDA releases the form FDA-483 issued to Indias Laurus Synthesis with five inspection observations.
FDA releases the form FDA-483 issued following an inspection at Indias Torrent Pharmaceuticals drug manufacturing facility.
Public Citizen asks FDA to revise its planned research on the misuse of drugs and other substances to ensure that no funding goes to the Researched Ab...
FDA alerts healthcare providers to not purchase or implant Synovos Total Hip System because modifications to the original device design were not clear...
Invivyd seeks FDA emergency use authorization for VYD222, which is described as a broadly neutralizing, half-life extended monoclonal antibody candida...
FDA approves Arcutis Biotherapeutics Zoryve topical foam to treat seborrheic dermatitis in individuals aged nine and older.
FDA issues a complete response letter for Zealand Pharmas dasiglucagon based on deficiencies at a third-party manufacturing facility.
FDA approves a label update for Kites Yescarta to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 study.
